BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RFG-3CF SYSTEM, 117 V/60 HZ

    MDR report key: 1443384 · Received June 3, 2009

    Report

    Report Number
    1717344-2009-00251
    Event Type
    Malfunction
    Date Received
    June 3, 2009
    Date of Event
    April 1, 2009
    Report Date
    May 4, 2009
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    NBN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT FOLLOWING A STANDARD NERVE ABLATION PROCEDURE FOR PAIN, THE PATIENT'S RIGHT SIDE HAS MOTOR AND SENSORY LOSS BELOW THE KNEE. THE LEFT SIDE ABLATION PROCEDURE WAS PERFORMED WITH NO ISSUES. THE PATIENT WAS BEING SEEN BY A NEUROLOGIST AND REHAB SPECIALIST. THE CUSTOMER REPORTED THEY DO NOT BELIEVE THERE ARE ANY ISSUES WITH THE GENERATOR BUT WANT TO GET IT CHECKED OUT AND ALSO DO NOT BELIEVE COVIDIEN ABLATION ACCESSORIES WERE IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RFG-3CF SYSTEM, 117 V/60 HZ RF ABLATION GENERATOR NBN COVIDIEN LP (VALLEYLAB) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK